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Chemotherapy Followed By Autologous Natural Killer Cells and Aldesleukin in Treating Patients With Metastatic Melanoma or Kidney Cancer

2014-08-27 03:43:27 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Aldesleukin may stimulate natural killer cells to kill tumor cells. Giving chemotherapy followed by autologous natural killer cells and aldesleukin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy followed by autologous natural killer cells and aldesleukin works in treating patients with metastatic melanoma or kidney cancer.

Description

OBJECTIVES:

Primary

- Determine the ability of the administration of autologous natural killer cells and aldesleukin after a nonmyeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma or renal cell cancer.

Secondary

- Determine the rate of repopulation of the natural killer cells in these patients.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients are stratified according to disease (melanoma vs renal cell cancer).

- Leukapheresis: Patients undergo apheresis to collect peripheral blood lymphocytes that are used for in vitro generation of autologous natural killer (NK) cell lymphocytes.

- Nonmyeloablative preparative regimen: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine phosphate IV over 15-30 minutes on days -5 to -1.

- Autologous NK cell infusion: Patients receive autologous NK cells IV over 20-30 minutes on day 0.

- Aldesleukin: Patients receive aldesleukin IV over 15 minutes every 8 hours beginning on day 0 and continuing for up to 5 days (maximum of 15 doses) during the first course and begin a second course 14 days later.

Patients who achieve partial or complete response and then develop progressive disease may receive 1 additional course of therapy as above.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

aldesleukin, therapeutic autologous lymphocytes, cyclophosphamide, fludarabine phosphate

Location

NCI - Surgery Branch
Bethesda
Maryland
United States
20892-1201

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:27-0400

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Medical and Biotech [MESH] Definitions

Lymphocytes that show specificity for autologous tumor cells. Ex vivo isolation and culturing of TIL with interleukin-2, followed by reinfusion into the patient, is one form of adoptive immunotherapy of cancer.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

Mucoproteins isolated from the kidney bean (Phaseolus vulgaris); some of them are mitogenic to lymphocytes, others agglutinate all or certain types of erythrocytes or lymphocytes. They are used mainly in the study of immune mechanisms and in cell culture.

A family of sodium-phosphate cotransporter proteins with eight transmembrane domains. They are present primarily in the KIDNEY and SMALL INTESTINE and are responsible for renal and small intestinal epithelial transport of phosphate.

A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

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